phase1a, dose-escalation study of nni-362 in healthy aged volunteers

Conditions: Alzheimer Disease

Summary: the purpose of this study is to examine the safety, tolerability and pharmacokinetics of single and multiple doses of nni-362 in healthy aged population.

the early clinical development strategy consists of the initial evaluation of safety and tolerability of nni-362. this fih phase i includes single and multiple ascending dose studies in healthy aged volunteers. assessment of suicidal ideation/behavior will be performed at baseline and at all study visits and on days of inpatient confinement in conformance with fda recommendations.

Eligibility criteria:
inclusion criteria: * healthy aged volunteers of either sex between the ages of 50 and 72 inclusive at time of screening. * subjects must be in reasonably good health as determined by investigator based on medical history, vital signs measurements, physical examination, screening laboratory results and ecg. * normal age-related findings as well as well-controlled, chronic and stable medical conditions (e.g., hypertension, osteoarthritis, non-insulin dependent diabetes mellitus, osteoporosis, gout, paget's disease, hypothyroidism) will not be exclusionary if they are not expected to compromise subject safety, study conduct, or study objectives. * non-interacting medications for stable allowable medical conditions will be allowed following review and approval by the medical monitor. * an adequate understanding of the requirements of the study, provision of written informed consent, and agreement to abide by the study restrictions. * negative urine screen for drugs of abuse within 24 h before the administration of the first dose of study drug and in the multiple dose study upon readmission to the clinical unit from outpatient status. * body mass index (bmi) of between 18 and 30 kg/m2 inclusive, and a total body weight greater than 48kg at screening. exclusion criteria: * • women of child-bearing potential, defined as premenopausal (unless the potential research subject has previously undergone hysterectomy and/or bilateral salpingo-oophorectomy) * pregnant or breastfeeding * any clinically significant hematology, chemistry, coagulation, or urinalysis value at screening and day -1 abnormal liver enzymes (alt and/or ast \>1.5x uln) at screening and day -1 * serum creatinine \> uln at screening and day -1 * hemoglobin \<13 g/dl for males or \<11.5 g/dl for females, leukocytes \<3.0 x 103/ul, absolute neutrophil count \<1000/ul, or platelets \<150 x 103/ul at screening and day -1 * any significant medical illness that could compromise the interpretability of study data or affect subject safety including, but not necessarily limited to: * chronic pulmonary disease or sleep apnea * clinically significant cardiac arrhythmia (either at screening or based on history) * congestive heart failure, valvular heart disease or ischemic heart disease * pulmonary hypertension * any disorder of the kidney or urinary tract * active peptic ulcer disease, gastrointestinal bleeding, inflammatory bowel disease, chronic pancreatitis * liver disease (excluding gilbert's syndrome) * any neurologic disorder other than chronic bell's palsy * history of malignancy that has not been cured or in complete remission for at least 10 years (excluding resected non-metastatic basal cell carcinoma) * history of seizure activity other than early childhood * any traumatic brain injury in adulthood * current smoker or nicotine user (quit less than 2 months) * active substance abuse. * glomerular filtration rate \<50 ml/min based on cockcroft-gault calculation using ideal (lean) body weight or present weight. * difficulty swallowing